BioCentury
ARTICLE | Company News

FDA again reviewing Novo insulins

April 8, 2015 12:31 AM UTC

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said FDA accepted for review resubmitted NDAs for Tresiba insulin degludec and Ryzodeg insulin degludec/insulin aspart to treat Type I and Type II diabetes in adults. The resubmissions of the two NDAs are based on an interim analysis of the Phase III DEVOTE trial, a CV outcomes trial FDA requested in a 2013 complete response letter. Novo expects to complete DEVOTE in 2H16 (see BioCentury Extra, Feb. 11, 2013). ...